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Anti-TNFα to Delay or Prevent Progression to Stage 3 T1D

NCT04729296 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2021-12-02

No results posted yet for this study

Summary

This will be a study conducted as a placebo-controlled, double blind, 1:1 randomized controlled clinical trial testing a Tumor Necrosis Factor Blocker (Anti-TNFα) substance versus placebo in subjects with a 2-year 50% risk of progression to stage 3 T1D across multiple centers. The trial will investigate the ability of Anti-TNFα to prevent or delay progression to Stage 3 T1D in the targeted patient population.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DRUG

Golimumab

For participants ≥45 kg, 50 mg of golimumab will be administered subcutaneously For participants \<45 kg, the dose of golimumab is 30 mg/m2 to maximum of 50 mg

DRUG

Placebo

Inactive Drug

Sponsors & Collaborators

  • University of South Florida

    collaborator OTHER

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • Carla Greenbaum, MD · Type 1 Diabetes TrialNet

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
46 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2027-07-01
Completion
2027-07-01
FDA Drug
Yes

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04729296 on ClinicalTrials.gov